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Methotrexate

Generic Name
Methotrexate
Brand Names
Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo
Drug Type
Small Molecule
Chemical Formula
C20H22N8O5
CAS Number
59-05-2
Unique Ingredient Identifier
YL5FZ2Y5U1
Background

Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division. Because of these effects, methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma.

Due to the toxic effects of methotrexate, it is indicated for treatment of some forms of arthritis and severe psoriasis only if first line treatment has failed or patients are intolerant of those treatments.

Methotrexate was granted FDA approval on 7 December 1953.

Indication

Methotrexate oral solution is indicated for pediatric acute lymphoblastic leukemia and pediatric polyarticular juvenile idiopathic arthritis. Methotrexate injections for subcutaneous use are indicated for severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe, recalcitrant, disabling psoriasis.

Other formulations are indicated to treat gestational choriocarcinoma, chorioadenoma destruens, hydatiform mole, breast cancer, epidermoid cancer of the head and neck, advanced mycosis fungoides, lung cancer, and advanced non-Hodgkin's lymphoma. It is also used in the maintenance of acute lymphocytic leukemia. Methotrexate is also given before treatment with leucovorin to prolong relapse-free survival following surgical removal of a tumour in non-metastatic osteosarcoma.

Associated Conditions
Acute Lymphoblastic Leukemia (ALL), Acute Promyelocytic Leukemia, Bladder Cancer, Breast Cancer, Central Nervous System Lymphoma, Crohn's Disease (CD), Dermatomyositis (DM), Extrauterine Pregnancy, Gestational Trophoblastic Neoplasia, Graft-versus-host Disease (GVHD), Meningeal leukemia, Multiple Sclerosis, Mycosis Fungoides (MF), Non-Hodgkin's Lymphoma (NHL), Non-Hodgkin's Lymphoma, Relapsed, Osteosarcoma, Polyarticular Juvenile Idiopathic Arthritis, Polymyositis, Rheumatoid Arthritis, Soft Tissue Sarcoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Systemic Lupus Erythematosus, Uveitis, Nonleukemic meningeal cancer, Refractory Non-Hodgkin's lymphoma, Refractory Takayasu arteritis, Severe Psoriasis
Associated Therapies
Medically induced abortion

Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

Completed
Conditions
Early Diffuse Cutaneous Systemic Sclerosis
Interventions
First Posted Date
2015-01-15
Last Posted Date
2016-05-13
Lead Sponsor
University of Manchester
Target Recruit Count
320
Registration Number
NCT02339441

Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

Completed
Conditions
Psoriasis
Inflammation
Interventions
First Posted Date
2015-01-01
Last Posted Date
2017-10-13
Lead Sponsor
University Hospitals Cleveland Medical Center
Target Recruit Count
26
Registration Number
NCT02330380
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement

Phase 2
Completed
Conditions
Diffuse Large B-cell Lymphoma
Interventions
First Posted Date
2014-12-31
Last Posted Date
2024-07-29
Lead Sponsor
International Extranodal Lymphoma Study Group (IELSG)
Target Recruit Count
76
Registration Number
NCT02329080
Locations
🇮🇹

IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy

🇮🇹

Villa Sofia - Cervello, Palermo, Italy

🇨🇿

Facultni nemocnice, Brno, Czechia

and more 33 locations

Peginterferon Alfa-2a to Enhance Anti-leukemic Responses After Allogeneic Transplantation in Acute Myeloid Leukemia

Phase 1
Completed
Conditions
Acute Myeloid Leukemia
Interventions
Drug: peg-IFN-α
Procedure: Hematopoietic Cell Transplant (HCT)
Drug: Tacrolimus
Drug: Methotrexate
First Posted Date
2014-12-31
Last Posted Date
2021-10-06
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
37
Registration Number
NCT02328755
Locations
🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas

Phase 4
Terminated
Conditions
Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Interventions
First Posted Date
2014-12-23
Last Posted Date
2022-01-13
Lead Sponsor
Polish Lymphoma Research Group
Target Recruit Count
100
Registration Number
NCT02323659
Locations
🇵🇱

Centrum Onkologii im. prof. F. Łukaszczyka, Bydgoszcz, Poland

Combination Therapy Prevents the Relapse of RA

Not Applicable
Conditions
Recurrence (Disease Attribute)
Interventions
Drug: Entanercept
Drug: MTX
Drug: HCQ
First Posted Date
2014-12-19
Last Posted Date
2020-06-22
Lead Sponsor
Peking University First Hospital
Target Recruit Count
240
Registration Number
NCT02320630
Locations
🇨🇳

Rheumatology and Immunology Department,Peking University First Hospital, Beijing, Beijing, China

A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
Biological: ALX-0061
Other: Placebo
Drug: Methotrexate
First Posted Date
2014-12-05
Last Posted Date
2019-08-21
Lead Sponsor
Ablynx, a Sanofi company
Target Recruit Count
345
Registration Number
NCT02309359
Locations
🇪🇸

Investigator Site, Santiago de Compostela, Spain

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Investigator Site 2, Belgrade, Serbia

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Investigator Site 3, Belgrade, Serbia

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A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2014-12-03
Last Posted Date
2024-10-28
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
519
Registration Number
NCT02305849
Locations
🇯🇵

JP00109, Nagoya, Aichi, Japan

🇯🇵

JP00068, Yatomi, Aichi, Japan

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JP00106, Kurume, Fukuoka, Japan

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SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

Phase 2
Active, not recruiting
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2014-11-24
Last Posted Date
2024-01-10
Lead Sponsor
UNICANCER
Target Recruit Count
1460
Registration Number
NCT02299999
Locations
🇫🇷

Hopitaux Universitaire de Strasbourg - Hopital Civil, Strasbourg, France

🇫🇷

Institut Claudius Regaud, Toulouse, France

🇫🇷

Hopitaux Du Leman, Thonon-les-Bains, France

and more 21 locations

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2014-11-19
Last Posted Date
2018-01-30
Lead Sponsor
Sanofi
Target Recruit Count
243
Registration Number
NCT02293902
Locations
🇯🇵

Investigational Site Number 392010, Asahi-Shi, Japan

🇯🇵

Investigational Site Number 392036, Chiba-Shi, Japan

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Investigational Site Number 392047, Fuchu-Shi, Japan

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